Data Reviewer

The Data Reviewer is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include review of assigned pre-submission applications, auditing regulatory pre-submission documents, and communicating any audit comments/observations/findings to respective stakeholders.

Requirements

• Bachelor of Science (B.S.) in Chemistry, Pharmacy, Biochemistry or related field
• Proficient in MS Office applications (Word, Excel)
• Excellent project management and problem solving skills